Sr Engineer (Software Test)
At a glance
Senior QA & Test role at Fresenius Kabi. North Andover · full-time · $98,000–$105,000 base.
techroles summary, based on the employer's posting.
What you'll do
- Create and carry out test cases for Ivenix infusion products, including newly developed and existing systems
- Judge whether results meet specifications, connect evidence to system requirements, and route issues through established channels
- Keep detailed test records for internal and external users, then organize project information for technical reviews
- Prepare and maintain test equipment and samples while following the procedures required in regulated work
- Resolve test issues within your scope and refer cases outside established limits to the appropriate team
What you bring
- You have executed and reported test cases, and can design manual tests for complex systems and components
- You bring strong software testing fundamentals, clear communication, and the ability to analyze problems
- You can speak, read, write, and understand English well enough to work independently with regulated documentation
Who this fits
This role suits a senior individual contributor who also works as part of a larger team. You’ll be onsite in North Andover three days each week. Applicants must be authorized to work for any U.S. employer; visa sponsorship is unavailable.
From the employer
Job Summary
An engineering position, under moderate supervision, participates in designing, building, and maintaining processes to test and verify software products used in medical devices and engineering projects related to medical technology. Applies standard engineering practices to resolve simple problems, and contributes to the validation and verification of software products.Hybrid: Onsite 3 days per week
Salary Range: $98,000-$105,000 based on experience
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.
Responsibilities
Defines and executes test cases for new and existing Ivenix Infusion System products. Following pre-established testing procedures. Ability to apply technical theories and principles. Accurately assess results for validity and conformance to specifications.
Develops and maintains detailed documentation for both internal and external customers. Traces test activities and results to system and subsystem requirements, escalating findings through the defined workflows.
Operates within defined processes and procedures consistent with a regulated environment. Works on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.
Effectively operates as an individual contributor and a member of the large team. Sets up and maintains test articles and test fixtures. Apply sound judgment to resolve routine and non-routine issues, follow established guidelines, and escalate when situations fall outside defined parameters.
Participates in technical reviews and is responsible for organizing data and preparing appropriate documentation for assigned projects.
Requirements:
• Bachelor’s degree in Engineering, Computer Science, or related field is preferred.
• Minimum 2 years of experience in a regulated industry (e.g., medical device, pharmaceutical, or other ISO/FDA‑governed environments) is preferred.
• Experience in medical device software development and testing is preferred.
• Experience working on a medical device or other regulated industry is preferred.
• Experience working in an Agile environment is preferred.
• Experience with test case execution and reporting is required.
• Experience in designing and developing manual test cases for complex systems and components is required.
• Excellent written and verbal communication skills.
• Thorough understanding of software test principles and best practices needed to produce high-quality software.
• Strong problem-solving and analytical skills.
• Proven ability to work collaboratively as part of a cross-functional team.
• Experience working in virtual environments. Experience with VMWare or Hyper-V is preferred.
• Experience testing devices with embedded Linux systems and/or platforms using IIS, ASP.NET, Web/Windows Services, and SQL is preferred.
• Experience with Windows Server administration, setup, deployment, and configuration, and the ability to interpret error logs are preferred.
• Proficiency with test‑automation tools such as Selenium WebDriver, Squish, and Python is preferred.
- The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.